BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIUM MRI INFUSION PUMP

    MDR report key: 3666912 · Received February 18, 2014

    Report

    Report Number
    3005053560-2014-00001
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    January 13, 2014
    Report Date
    February 17, 2014
    Manufacturer
    IRADIMED CORPORATION
    Product Code
    FRN
    Removal / Correction Number
    3005053560-09/17/12-002-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE EXAMINATION OF THE PUMP, DETERMINED THE PRODUCT WAS FOUND TO OPERATE TO SPECIFICATION. THE HOSPITAL STAFF DETERMINED THAT THEY COULD REPRODUCE THE EVENT WITH THE INFUSION SET USED DURING THE EVENT, BUT THIS HAS NOT BEEN ASCERTAINED BY IRADIMED CORPORATION. UPON RECEIPT OF THIS INFUSION SET, IRADIMED WILL EVALUATE THIS INFUSION SET, AND ATTEMPT TO REPRODUCE THE EVENT. FROM THE AVAILABLE INFORMATION, IT WAS CONSIDERED LIKELY THAT THE CAUSE OF THIS EVENT WAS THE ACCIDENTAL STRETCHING OF THE INFUSION SET'S SILICONE RUBBER SECTION OF THE SET. THIS IS CONTRAINDICATED IN THE INSTRUCTIONS FOR LOADING THE INFUSION SET. AFTER THE 1058 INFUSION SET IS RECEIVED FROM THE HOSPITAL, AND AN EXAMINATION OF THE INFUSION SET IS PERFORMED, AN UPDATE WILL BE PROVIDED IF THE RESULTS OF THE EXAMINATION INDICATE A DIFFERENT CAUSE OF THIS EVENT. IT WAS ALSO REQUESTED THAT THE HOSPITAL PROVIDE OTHER SAMPLES OF THEIR SETS FOR EXAMINATION AS WELL. THE SETS BEING USED STILL HAVE THE OLDER BLUE SLEEVE PROTECTOR THAT, WHEN REMOVED AGGRESSIVELY, CAN RESULT IN THE TUBING BECOMING STRETCHED. INVESTIGATION CONCLUSIONS: THE EXAMINATION OF THE PUMP DETERMINED THE 3860 PUMP AND INFUSION SET OPERATED NORMALLY. NO PROBLEM WAS IDENTIFIED WITH THE PUMP THAT COULD HAVE CAUSED THIS EVENT. THE INFUSION SET USED DURING THE EVENT AND IT HAS NOT BEEN EXAMINED BY IRADIMED CORPORATION. FROM THE INFORMATION AVAILABLE, NO FIRM CONCLUSIONS CAN BE MADE AS TO WHAT CAUSED THIS EVENT. FROM THE CUSTOMER'S EXAMINATION OF THE PUMP AND INFUSION SET USED DURING THE EVENT, THE HISTORY EVENT LOG ASSESSMENT, AND INFORMATION FROM THE HOSPITAL STAFF USING THE PUMP, THE PROBABLE CAUSE OF THIS REPORT WAS THE STRETCHING OF THE INFUSION SET IN THE PUMP BY THE USER. THE PROPER METHOD OF INSTALLATION IS DESCRIBED IN THE OPERATOR'S MANUAL. THE INSTRUCTIONS WARN THAT STRETCHING THE TUBING CAN RESULT IN FREE-FLOW CONDITIONS. IN (B)(4) 2012, IRADIMED CORPORATION INITIATED CORRECTION NO. 3005053560-09/17/12-002-C ON 08/31/2012 TO NOTIFY USERS OF THE POSSIBILITY OF THIS RISK. THESE SAME INSTRUCTIONS ARE PROVIDED IN THE OPERATOR'S MANUAL, BUT AN ADDITIONAL INSTRUCTION CARD WAS PROVIDED TO USERS TO EMPHASIZE THESE IMPORTANT INSTRUCTIONS AND PRECAUTIONS. THE CUSTOMER DID HAVE THE INSTRUCTION CARD AVAILABLE WHERE THIS PUMP WAS BEING USED. COPIES OF THE CORRECTION AND INSTRUCTION CARD TEXT ARE PROVIDED WITH THIS REPORT. FOLLOW-UP IN-SERVICE TRAINING IS BEING RECOMMENDED BY IRADIMED CORPORATION TO THE FACILITY'S STAFF. INTERNAL REFERENCE: (B)(4).

    Description of Event or Problem · 1

    DURING AN MRI SCAN, A PATIENT'S INFUSION WAS STARTED WITH 2 SEPARATE INFUSION LINES (MORPHINE AND DOPAMINE). A SHORT TIME AFTER THE INFUSION WAS STARTED, THE NURSE OBSERVED THAT SHE THOUGHT THE DOPAMINE INFUSION WAS DELIVERING FASTER THAN EXPECTED. THIS INFUSION WAS PROGRAMMED FOR 14 ML/HR, WITH A MEDICATION BAG VOLUME OF 250 ML. THE INFUSION WAS DISCONTINUED WITHOUT HARM TO THE PATIENT, AND IT IS BELIEVED THE MR PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT. NO PATIENT INJURY RESULTED FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102285 MRIDIUM MRI INFUSION PUMP INFUSION PUMP FRN IRADIMED CORPORATION 3860

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR